PleurX Pleural Catheter and Starter Kit - For Pleural Placement Only and For Patient Home Use

PleurX Pleural Catheter and Starter Kit
PleurX - 50-7700

A collection of sterile devices designed for catheterization of the pleural cavity and/or peritoneal cavity for drainage and/or aspiration of effusions, ascites, and/or air. It includes a pleural catheter and/or a peritoneal catheter typically with catheter introduction devices (e.g., needles, scalpel, tunneller). It also includes additional non-dedicated catheterization support devices (e.g., disposable scissors, gloves, dressings), drainage receptacle (e.g., collection bottle), and/or suction system regulator; it does not include any powered pumps or pharmaceuticals. This is a single-use device.

• Total Volume: 1000 Milliliter
• Catheter Gauge: 15.5 French

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: DWM

Device Name: Apparatus, Suction, Patient Care

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: AN

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 870.5050

Third Party Flag: Y

Medical Specialty: CV

Device Id: 50885403231528

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403231520

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Case

Device Id: 10885403231520

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Device Id: 20885403231527

Device Type: Package

DeviceId Issuing Agency: GS1

Contains DI Number: 10885403231520

Package Quantity: 1

Package Discontinue Date: N/A

Package Status: In Commercial Distribution

Package Type: Box